21 CFR § 207.21 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code

§ 207.21 When must initial registration information be provided?

Current through Sep 8, 2026 · Read all of Part 207

⚠ 2 pending changes to Part 207

(a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.

(b) Registrants must register each foreign establishment before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import into the United States.

← § 207.17 Who must register?§ 207.25 What information is required for registration? →